Amoxicillin and clavulanic acid Sandoz GmbH
ItalyTable of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Amoxicillin and Clavulanic Acid Sandoz GmbH
875 mg + 125 mg granules for oral suspension
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Amoxicillin and Clavulanic Acid Sandoz GmbH is and what it is used for
- What you need to know before taking Amoxicillin and Clavulanic Acid Sandoz GmbH
- How to take Amoxicillin and Clavulanic Acid Sandoz GmbH
- Possible side effects
- How to store Amoxicillin and Clavulanic Acid Sandoz GmbH
- Contents of the pack and other information
1. What Amoxicillin and Clavulanic Acid Sandoz GmbH is and what it is used for
Amoxicillin and Clavulanic Acid Sandoz GmbH is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines called "penicillins," whose activity can be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Sandoz GmbH is used in adults and children to treat the following infections:
- Middle ear and sinus infections;
- Respiratory tract infections;
- Urinary tract infections;
- Skin and soft tissue infections, including dental infections;
- Bone and joint infections.
2. What you need to know before taking Amoxicillin and Clavulanic Acid Sandoz GmbH
Do not take Amoxicillin and Clavulanic Acid Sandoz GmbH
- if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to any of the other ingredients of this medicine (listed in section 6);
- if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This also includes skin rash or swelling of the face or neck.
- if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take Amoxicillin and Clavulanic Acid Sandoz GmbH if any of the above apply to you.
If you have any doubts, contact your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Sandoz GmbH.
Warnings and precautions
Contact your doctor or pharmacist before taking this medicine if you:
- have infectious mononucleosis;
- have previously been treated for liver or kidney problems;
- do not urinate regularly.
If you are unsure whether any of the conditions described above apply to you, contact your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Sandoz GmbH.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection. Based on the results, they may prescribe a different dose of Amoxicillin and Clavulanic Acid Sandoz GmbH or a different medicine.
Conditions requiring special attention
Amoxicillin and Clavulanic Acid Sandoz GmbH may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should pay attention to certain symptoms while taking Amoxicillin and Clavulanic Acid Sandoz GmbH in order to reduce any risks. See “Conditions requiring special attention” in Section 4.
Blood and urine tests
If you are about to have blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Sandoz GmbH. This is because Amoxicillin and Clavulanic Acid Sandoz GmbH may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Sandoz GmbH, you are very likely to develop an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust the dose of Amoxicillin and Clavulanic Acid Sandoz GmbH.
If you are taking other medicines together with Amoxicillin and Clavulanic Acid Sandoz GmbH (such as warfarin) that help prevent blood clots, additional blood tests may be necessary.
Amoxicillin and Clavulanic Acid Sandoz GmbH may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).
Amoxicillin and Clavulanic Acid Sandoz GmbH may affect the action of mycophenolate mofetil (a medicine used to treat cancer or rheumatic diseases).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Sandoz GmbH may cause side effects, and the symptoms could make you unfit to drive. Do not drive or operate machinery unless you feel well.
Amoxicillin and Clavulanic Acid Sandoz GmbH contains aspartame.
This medicine contains aspartame (E951), which is a source of phenylalanine. This substance may be harmful to patients with phenylketonuria.
3. How to take Amoxicillin and Clavulanic Acid Sandoz GmbH
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Adults and children weighing 40 kg or more
- Usual dose – 1 sachet twice daily
- Higher dose – 1 sachet three times daily
Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid Sandoz GmbH 875 mg/125 mg sachets are not recommended.
Patients with liver or kidney problems
- If you have kidney problems, your dose may need to be adjusted. Your doctor may prescribe a different dosage or a different medicine.
- If you have liver problems, more frequent blood tests may be required to monitor liver function.
How to take Amoxicillin and Clavulanic Acid Sandoz GmbH
- Just before taking Amoxicillin and Clavulanic Acid Sandoz GmbH, open the sachet and mix the contents in half a glass of water.
- Take the medicine at the beginning of a meal or just before eating.
- Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
- Do not take Amoxicillin and Clavulanic Acid Sandoz GmbH for longer than 2 weeks. If you do not feel better, you should see your doctor again.
If you take more Amoxicillin and Clavulanic Acid Sandoz GmbH than you should
If you take too much Amoxicillin and Clavulanic Acid Sandoz GmbH, symptoms may include stomach disturbances (nausea, vomiting, or diarrhoea) or seizures. Inform your doctor as soon as possible. Take the medicine pack with you to show your doctor.
If you forget to take Amoxicillin and Clavulanic Acid Sandoz GmbH
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
If you stop treatment with Amoxicillin and Clavulanic Acid Sandoz GmbH
Continue taking Amoxicillin and Clavulanic Acid Sandoz GmbH until the treatment is complete, even if you feel better. You need every dose to help fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any questions about how to use this medicine, contact your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur with this medicine.
Situations to watch out for:
Allergic reactions
- Skin rash
- Inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
- Fever, joint pain, swelling of the glands in the neck, armpits or groin
- Swelling, sometimes of the face or mouth ( angioedema ), causing difficulty in breathing
- Collapse
Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillina e Acido Clavulanico Sandoz GmbH.
Inflammation of the large intestine
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.
- If you experience these symptoms, contact your doctor immediately for advice.
Very common side effects (may affect more than 1 in 10 people)
- Diarrhoea (in adults)
Common side effects (may affect up to 1 in 10 people)
- Thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
- Feeling unwell (nausea), especially when taking high doses → if affected, take Amoxicillina e Acido Clavulanico Sandoz GmbH before food
- Vomiting
- Diarrhoea (in children)
Uncommon side effects (may affect 1 in 100 people)
- Skin rash, itching
- Raised skin rash and itching ( urticaria )
- Indigestion
- Dizziness
- Headache
Uncommon side effects may be detected in blood tests:
- Increase in certain substances ( enzymes ) produced by the liver
Rare side effects (may affect 1 in 1,000 patients)
- Skin rashes, which may appear as blisters and look like small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ) → if you notice any of these symptoms, contact a doctor urgently
Rare side effects that may be detected in blood tests:
- Low number of cells involved in blood clotting
- Low number of white blood cells
Frequency not known (frequency cannot be estimated from the available data)
- Allergic reactions (see above)
- Inflammation of the large intestine (see above)
- Inflammation of the protective membrane surrounding the brain ( aseptic meningitis )
- Severe skin reactions:
─ widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis )
─ widespread red rash with small blisters containing pus ( exfoliative bullous dermatitis )
─ red skin reaction with crusts, swellings under the skin and blisters ( exanthematous pustulosis ) - If you experience any of these symptoms, contact your doctor immediately
- Inflammation of the liver ( hepatitis )
- Jaundice, caused by increased levels of bilirubin (a substance produced by the liver) in the blood, which may make the skin and whites of the eyes appear yellow
- Inflammation of the kidney tubules
- Blood takes longer to clot
- Hyperactivity
- Seizures (in patients taking high doses of Amoxicillina e Acido Clavulanico Sandoz GmbH or who have kidney problems)
- Black hairy tongue (black, hair-like appearance of the tongue)
- Tooth staining (in children), usually removable by brushing
Side effects that may be detected in blood or urine tests:
- Severe reduction in white blood cell count
- Low red blood cell count ( haemolytic anaemia )
- Crystals in the urine
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the National Reporting System at: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Amoxicillin and Clavulanic Acid Sandoz GmbH
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use Amoxicillin and Clavulanic Acid Sandoz GmbH after the expiry date stated on the packaging following the term EXP. The expiry date refers to the last day of that month.
After reconstitution, the oral suspension must be used immediately.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Amoxicillina e Acido Clavulanico Sandoz GmbH contains
The active substances are amoxicillin and clavulanic acid.
Each sachet contains:
- amoxicillin trihydrate 1004.5 mg, equivalent to 875 mg of amoxicillin
- clavulanic acid, potassium salt 148.9 mg, equivalent to 125 mg of clavulanic acid.
The other ingredients are: magnesium stearate, precipitated silica, sodium croscarmellose, microcrystalline cellulose, aspartame (E951) and lemon-peach-strawberry flavour.
Description of the appearance of Amoxicillina e Acido Clavulanico Sandoz GmbH and package contents
Amoxicillina e Acido Clavulanico Sandoz GmbH is available as sachets containing 1.8 g of granules for oral suspension.
The sachets are composed externally of layers of: paper/polyethylene/aluminium/polyethylene.
Amoxicillina e Acido Clavulanico Sandoz GmbH contains 12 sachets.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10, Kundl 6250, Austria
Legal representative in Italy:
Sandoz S.p.A.
Largo Umberto Boccioni, 1 - Origgio (VA)
Responsible manufacturer for batch release:
Sandoz GmbH
Biochemiestrasse 10, Kundl 6250, Austria
This leaflet was last approved on: